Review of draft guidance - Complying with the Unique Device Identification regulations for medical devices

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on a new guidance document being drafted for the Australian UDI system:

‘Complying with the Unique Device Identification regulations for medical devices.’  

Please note the following:

• This document will be published in the TGA's new Guidance format as a web page that can be downloaded or printed as a PDF
• This document does not contain information about UDI implementation dates as these will be published separately as standalone Guidance 
• UDI regulations are yet to be approved or finalised by the Australian Government and the requirements described in this document are subject to change
• Wording is present tense and references are made to documents or publications not yet available. 

Why your views matter

This guidance explains the new regulatory requirements for Australia’s Unique Device Identification (UDI) system for identifying medical devices and in vitro diagnostic (IVD) devices. The UDI system is expected to be in effect from early 2025.

Your input is important to ensure the draft guidance is valuable and outlines the background and key changes for the UDI system and explains the steps for sponsors and manufacturers to comply with the new requirements.